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News release

Baxter Launches First 3-in-1 Set for Use in Continuous Renal Replacement Therapy and Sepsis Management Protocols

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  • New indication for oXiris set to help remove excessive levels of cytokines and endotoxin in patients needing blood purification launched at ESICM
  • Elevated levels of inflammatory mediators cytokines and endotoxin are frequently seen in patients with sepsis, a serious medical condition affecting up to 40 percent of critically ill patients in the intensive care unit1-7
  • First approved use for oXiris outside of CRRT and fluid overload, adds to Baxter’s multi-organ therapy offering using the Prismaflex system

VIENNA--(BUSINESS WIRE)--Sep. 26, 2017-- Baxter International Inc. (NYSE: BAX), a global leader in acute care therapies, announced today the commercial launch of a new indication for the company’s oXiris set, which can now be used to help remove excessive levels of cytokines, endotoxin and other inflammatory mediators from a patient’s blood. This makes oXiris the first blood purification set that can be used in continuous renal replacement therapy (CRRT) and sepsis management protocols. Baxter showcased the new indication at this week’s European Society of Intensive Care Medicine (ESICM) congress.

Previously, the oXiris set was only indicated for CRRT, which is a type of extracorporeal (outside the body) blood purification (EBP) used with Baxter’s Prismaflex system to manage patients with acute kidney injury (AKI).

The use of EBP to remove cytokines and endotoxin from the blood represents a promising approach to treat conditions where excessive levels of those inflammatory mediators are seen in the patient’s blood. For that reason, EBP is being studied for its potential to help address sepsis, a condition for which new therapeutic approaches have not shown to be effective.8 However, confirmation of such an association is challenging, in part due to the population of critically ill patients with AKI and/or sepsis, and because these patients often require multiple therapeutic interventions9 – a characteristic that complicates assessment of individual treatment outcomes.

“Extracorporeal blood purification for sepsis is an area where we do not have a lot of robust published research and where there is little scientific consensus, so it’s difficult for healthcare providers to determine the most effective way to treat their patients,” said Thomas Rimmelé, M.D., PhD, chairman of the Anesthesia and Resuscitation Service Department at Hôpital Edouard Herriot in Lyon, France. “What I find most interesting about the oXiris set is that it is now able to filter the blood of cytokines and endotoxin while simultaneously treating acute kidney injury.”

“Baxter is leading the way in advancing treatments for the most critically ill patients in a hospital and finding innovative solutions where there are few effective options available today,” said Reaz Rasul, general manager of Acute Therapies at Baxter. “This launch illustrates our commitment to providing healthcare providers with new applications for products used on our leading Prismaflex system to drive better care.”

Baxter received CE mark and regulatory approval for the label expansion in more than 30 countries in Europe and certain countries in the Middle East and Africa. The new indication is also planned for Hong Kong. Baxter currently plans to file for the expanded indication in additional countries in 2018 and beyond. The oXiris set is not currently approved in the United States.

About Our Acute Therapies Portfolio

A leader in multi-organ support therapy options, Baxter has been at the forefront of advancing new technologies and revolutionizing treatment for critically ill patients around the world. Baxter’s leading Prismaflex system offers clinicians the flexibility to meet patients’ diverse needs and powers our portfolio of products to deliver a complete range of extracorporeal (outside the body) blood purification (EBP) therapies to help manage patients with AKI, acute respiratory distress syndrome, autoimmune diseases and/or sepsis. Prismax, Baxter’s next generation EBP system, is currently expected to launch commercially in select countries in 2018.

About Baxter

Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

This release includes forward-looking statements concerning Baxter and its oXiris set and its Prismaflex and Prismax systems, including oXiris’ indications, use, effectiveness and risks and expectations with regard to its availability in countries in Europe, the Middle East, Africa, Asia Pacific and other countries in the future. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply issues; patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

Baxter, Prismaflex and oXiris are trademarks of Baxter International Inc. or its subsidiaries.

1. Pavon A, Binquet C, Kara F, et al. Profile of the risk of death after septic shock in the present era: an epidemiologic study. Crit Care Med. 2013;41:2600-2609.
2. Blanco J, Muriel-Bombin A, Sagredo V, et al. Incidence, organ dysfunction and mortality in severe sepsis: a Spanish multicentre study. Crit Care. 2008;12:R158.
3. Engel C, Brunkhorst FM, Bone HG, et al. Epidemiology of sepsis in Germany: results from a national prospective multicenter study. Intensive Care Med. 2007;33:606-618.
4. Finfer S, Bellomo R, Lipman J, French C, Dobb G, Myburgh J. Adult-population incidence of severe sepsis in Australian and New Zealand intensive care units. Intensive Care Med. 2004;30:589-596.
5. Karlsson S, Varpula M, Ruokonen E, et al. Incidence, treatment, and outcome of severe sepsis in ICU-treated adults in Finland: the Finnsepsis study. Intensive Care Med. 2007;33:435-443.
6. Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014;311:1308-1316.
7. Sjoding MW, Prescott HC, Wunsch H, Iwashyna TJ, Cooke CR. Longitudinal changes in ICU admissions among elderly patients in the United States. Crit Care Med. 2016;44:1353-1360.
8. Rhodes A, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med 2017; 45:486–552.
9. Hébert PC, et al. Chest 2002;121:1290 – 300.

Source: Baxter International Inc.

Baxter International Inc.
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